Siemens Artis icono X-Ray Systems Recalled for Potential Hardware Failure
Siemens has recalled Artis icono X-ray imaging systems due to a potential hardware issue affecting a specific lot of X-ray tubes. If the error detection mechanism fails, the system cannot release X-rays until it is shut down.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses, injuries, or deaths. The hazard is a potential hardware failure that could prevent device operation but has not resulted in reported patient harm. Per the rubric, recalls with theoretical risk where injury has not been reported are classified as High.
Plain-English summary
Siemens Medical Solutions USA, Inc. has issued a recall for certain serial numbers of the Artis icono biplane (Model No. 11327600) and Artis icono floor (Model No. 11327700) X-ray imaging systems. These systems are affected by a potential hardware issue involving a specific lot of X-ray tubes.
The issue involves the error detection mechanism. In rare cases, if this mechanism fails, the system will not be able to release X-rays until it is shut down and restarted. This could interrupt diagnostic imaging operations.
A total of 1,389 units are affected, including 590 in the United States and 799 outside the United States. These systems have been distributed worldwide to medical facilities.
Healthcare facilities with affected Artis icono systems should verify their device serial numbers against the FDA recall notice and contact Siemens Medical Solutions for guidance and any available corrections or updates.
The recalled product
- Product
- Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- device-malfunction
- error-detection-failure
Distribution
Distributed nationwide across the United States.
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